Research Manager

Minnesota Epilepsy Group; Roseville (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Minnesota Epilepsy Group, P.A. seeks a Research Manager to oversee planning, coordination, and execution of clinical research in an outpatient neurology/epilepsy setting.

You will lead study teams, manage regulatory and data quality, and collaborate with investigators and sponsors to deliver patient-centered epilepsy trials. You will supervise coordinators, develop workflows, ensure GCP/HIPAA compliance, and optimize recruitment while maintaining high safety and ethical standards in outpatient

Qualifications

• Several years of clinical research experience, preferably in neurology, epilepsy, or another specialty clinical research environment.
• Experience coordinating or managing clinical trials.
• Knowledge of GCP, IRB requirements, informed consent, HIPAA, and applicable clinical research regulations.
• Demonstrated ability to manage multiple studies, competing priorities, and time-sensitive deliverables.
• Experience providing leadership, supervision, or mentorship to research staff.
• Strong organizational, communication, problem-solving, and interpersonal skills.

Responsibilities

• Oversee day-to-day operations of clinical trials and research studies conducted within the outpatient practice.
• Coordinate study start-up, including feasibility assessments, site activation, regulatory documentation, staff training, and study implementation.
• Develop and maintain study-specific workflows, timelines, tracking tools, and standard operating procedures.
• Monitor study enrollment, recruitment, retention, visit completion, and overall study performance.
• Coordinate research activities with routine epilepsy and neurology clinical care.
• Identify operational barriers and develop solutions to maintain study timelines and quality.
• Support clinical research involving epilepsy, seizure disorders, antiseizure medications, devices, diagnostics, and other neurological therapies as applicable.
• Coordinate protocol-required patient visits, assessments, laboratory testing, imaging, EEG-related procedures, medication management, and follow-up activities.
• Work closely with physician investigators and clinical staff to ensure protocol requirements are incorporated appropriately into patient care workflows.
• Support identification and screening of potentially eligible patients while maintaining appropriate privacy and ethical standards.
• Supervise, mentor, and provide day-to-day direction to research coordinators and other research personnel.
• Assign responsibilities and workload based on study requirements and staff competencies.
• Develop onboarding and continuing education programs for research personnel.
• Ensure research staff maintain competency in study protocols, informed consent, GCP, regulatory requirements, and applicable clinical procedures.
• Participate in recruitment, performance evaluation, professional development, and retention of research staff.
• Ensure research activities comply with study protocols, IRB requirements, Good Clinical Practice (GCP), HIPAA, FDA requirements, and applicable institutional policies.
• Oversee preparation and maintenance of regulatory and essential study documentation/investigator site files.
• Coordinate IRB submissions, amendments, continuing reviews, safety reports, and study closeout activities.
• Monitor and address protocol deviations, compliance concerns, and corrective/preventive actions.
• Maintain readiness for sponsor monitoring visits, audits, and regulatory inspections.
• Develop strategies to improve recruitment and enrollment for epilepsy clinical trials.
• Monitor recruitment metrics and identify opportunities to improve participant identification and retention.
• Promote a patient-centered research experience appropriate for individuals with epilepsy and their families/caregivers.
• Ensure informed consent and research participation processes are conducted appropriately and ethically.
• Coordinate research visits to minimize disruption to patients’ routine clinical care.
• Oversee accurate, complete, and timely collection of clinical research data.
• Monitor electronic data capture systems and ensure timely resolution of data queries.
• Review study documentation for accuracy, completeness, and protocol compliance.
• Track key performance indicators related to enrollment, data quality, visit completion, and study timelines.
• Implement quality-improvement processes to strengthen research operations.
• Serve as an operational point of contact for pharmaceutical/biotechnology sponsors, CROs, vendors, and research partners.
• Coordinate sponsor meetings, monitoring visits, site communications, and follow-up activities.
• Communicate study progress, enrollment status, operational issues, and corrective actions to investigators and study partners.
• Assist with study budgets, invoices, contracts, and resource planning as appropriate.

Skills

Clinical research management

GCP compliance

IRB management

Data quality management

Sponsor/CRO relationship management

Project and time management

Cross-functional collaboration

Patient-centered communication

Job description

Minnesota Epilepsy Group, P.A. – Outpatient Neurology/Epilepsy Setting

Position Summary

The Research Manager oversees the planning, coordination, and operational execution of clinical research activities within Minnesota Epilepsy Group, P.A. This position supports clinical trials and other research initiatives involving patients with epilepsy and related neurological conditions in an outpatient practice environment.

The Research Manager provides leadership to research staff, collaborates closely with physician investigators and clinical teams, and serves as a key point of contact for study sponsors, contract research organizations (CROs), institutional review boards (IRBs), vendors, and other research partners.

The role is responsible for maintaining high standards of participant safety, regulatory compliance, data integrity, study performance, and patient-centered research operations.

Essential Responsibilities

Clinical Research Operations

• Oversee day-to-day operations of clinical trials and research studies conducted within the outpatient practice.
• Coordinate study start-up, including feasibility assessments, site activation, regulatory documentation, staff training, and study implementation.
• Develop and maintain study-specific workflows, timelines, tracking tools, and standard operating procedures.
• Monitor study enrollment, recruitment, retention, visit completion, and overall study performance.
• Coordinate research activities with routine epilepsy and neurology clinical care.
• Identify operational barriers and develop solutions to maintain study timelines and quality.

Epilepsy Clinical Trials

• Support clinical research involving epilepsy, seizure disorders, antiseizure medications, devices, diagnostics, and other neurological therapies as applicable.
• Coordinate protocol-required patient visits, assessments, laboratory testing, imaging, EEG-related procedures, medication management, and follow-up activities.
• Work closely with physician investigators and clinical staff to ensure protocol requirements are incorporated appropriately into patient care workflows.
• Support identification and screening of potentially eligible patients while maintaining appropriate privacy and ethical standards.

Research Team Leadership

• Supervise, mentor, and provide day-to-day direction to research coordinators and other research personnel.
• Assign responsibilities and workload based on study requirements and staff competencies.
• Develop onboarding and continuing education programs for research personnel.
• Ensure research staff maintain competency in study protocols, informed consent, GCP, regulatory requirements, and applicable clinical procedures.
• Participate in recruitment, performance evaluation, professional development, and retention of research staff.

Regulatory & Compliance

• Ensure research activities comply with study protocols, IRB requirements, Good Clinical Practice (GCP), HIPAA, FDA requirements, and applicable institutional policies.
• Oversee preparation and maintenance of regulatory and essential study documentation/investigator site files.
• Coordinate IRB submissions, amendments, continuing reviews, safety reports, and study closeout activities.
• Monitor and address protocol deviations, compliance concerns, and corrective/preventive actions.
• Maintain readiness for sponsor monitoring visits, audits, and regulatory inspections.

Participant Recruitment & Patient Experience

• Develop strategies to improve recruitment and enrollment for epilepsy clinical trials.
• Monitor recruitment metrics and identify opportunities to improve participant identification and retention.
• Promote a patient-centered research experience appropriate for individuals with epilepsy and their families/caregivers.
• Ensure informed consent and research participation processes are conducted appropriately and ethically.
• Coordinate research visits to minimize disruption to patients’ routine clinical care.

Data & Quality Management

• Oversee accurate, complete, and timely collection of clinical research data.
• Monitor electronic data capture systems and ensure timely resolution of data queries.
• Review study documentation for accuracy, completeness, and protocol compliance.
• Track key performance indicators related to enrollment, data quality, visit completion, and study timelines.
• Implement quality-improvement processes to strengthen research operations.

Sponsor & CRO Relationships

• Serve as an operational point of contact for pharmaceutical/biotechnology sponsors, CROs, vendors, and research partners.
• Coordinate sponsor meetings, monitoring visits, site communications, and follow-up activities.
• Communicate study progress, enrollment status, operational issues, and corrective actions to investigators and study partners.
• Assist with study budgets, invoices, contracts, and resource planning as appropriate.

Required Qualifications

• Several years of clinical research experience, preferably in neurology, epilepsy, or another specialty clinical research environment.
• Experience coordinating or managing clinical trials.
• Knowledge of GCP, IRB requirements, informed consent, HIPAA, and applicable clinical research regulations.
• Demonstrated ability to manage multiple studies, competing priorities, and time-sensitive deliverables.
• Experience providing leadership, supervision, or mentorship to research staff.
• Strong organizational, communication, problem-solving, and interpersonal skills.

Preferred Qualifications

• Experience with epilepsy or neurological clinical trials.
• Experience with pharmaceutical-sponsored Phase I–IV clinical trials.
• Experience working with CROs and industry sponsors.
• Experience with electronic data capture (EDC), electronic regulatory systems, and clinical trial management systems.
• Experience with study budgets, contracts, and financial tracking.
• Experience preparing for sponsor audits, monitoring visits, or regulatory inspections.

Key Competencies

• Clinical trial management
• Epilepsy/neurology research
• Research staff leadership
• Patient recruitment and retention
• Regulatory compliance
• IRB management
• GCP compliance
• Data quality management
• Sponsor/CRO relationship management
• Project and time management
• Quality improvement
• Cross-functional collaboration
• Patient-centered communication

What Success Looks Like

A successful Research Manager will help Minnesota Epilepsy Group maintain a well-organized, compliant, and patient-centered research program while supporting investigators and research staff in delivering high-quality epilepsy clinical trials. The position requires balancing research requirements with the realities of outpatient clinical care and ensuring that patients receive a consistent, professional research experience.